Tool for facilitating the connecting of a catheter or other tubular member onto a guide-wire without access to the ends of the guide-wire

ABSTRACT

An attachment tool to facilitate the attachment of a catheter or similar elongated instrument to a guide-wire or other elongated guide member, without requiring access to either end of said wire or member. Said tool providing repeatable and reliable alignment of components to be attached, while being operated with a single hand. The tool further facilitates the attachment of a plurality of catheters or instruments to a single wire or member.

RELATED APPLICATION CROSS REFERENCE

The present application is a divisional application of U.S. patentapplication Ser. No. 09/861,728, filed on May 21, 2001, now U.S. Pat.No. 6,517,518 which is a continuation-in-part of U.S. patent applicationSer. No. 09/523,077, filed Mar. 10, 2000, which is assigned to the sameassignee as this invention and whose contents are fully incorporated byreference herein.

FIELD OF THE INVENTION

This invention relates generally to medical devices and moreparticularly to devices for use with catheters or other tubular devicesthat are arranged to be located at some intra-lumenal, e.g.,intra-vascular, position within the body of a being by a conventionalguide-wire or other guide member.

BACKGROUND OF THE INVENTION

Heretofore the mounting of a tubular instrument, e.g., a catheter, on aguide-wire has typically required access to either the distal or theproximal end of the guide-wire. Where the guide-wire is already inplace, access has been achieved by mounting the instrument on theproximal end of the guide-wire and then sliding it into place over oralong the guide-wire. For example, the so-called “over-the-wire”catheter (such as a balloon angioplasty catheter) has a central or otherlongitudinal extending passageway therethrough arranged to receive theguide-wire. In particular, the passageway of such a catheter isintroduced on the proximal end of the guide-wire and then the catheteris slid down the guide-wire to the desired location. The advantage ofthis type of instrument and guidance system is that it can have arelatively small cross-sectional area or “crossing-diameter,” a featureof some importance in applications wherein the lumen being traversed issmall, e.g., an artery occluded by atherosclerotic deposits. Theso-called “mono-rail” catheter doesn't make use of a central passagewayfor receipt of the guide-wire, but instead makes use of some externallylocated connector located on the distal end of the catheter and arrangedto receive the guide-wire through it. The mono-rail catheter is alsoarranged to be introduced on the proximal end of the guide-wire, butoutside the guide-wire so that the guide-wire passes through theconnector on the distal end of the catheter, with the catheter itselfbeing located beside the guide-wire so that it can be slid along theguide-wire to the desired location.

As will be appreciated by those skilled in the art, if the proximal endof the guide-wire has some structure permanently or transiently mountedor secured on it, e.g., a twist or torque handle (for rotating theguide-wire to a desired angular orientation), a valve (to enable somefluid to be introduced through the guide-wire, such as to inflate aballoon on the distal end of the guide-wire), another catheter, etc.,that is of a relatively large diameter or cross-sectional area, such aproximally mounted structure would necessarily impede the mounting ofthe instrument over the guide-wire once the guide-wire is in placewithin the being's body.

In U.S. Pat. No. 6,022,336 (Zadno-Azis et al.) there is disclosed acatheter system for revascularizing an occluded vessel and forcontaining any emboli produced during the use of the system. As bestseen in FIGS. 7 and 10A of that patent the instrument makes use ofplural catheters for providing at least one pair of paths for irrigationand aspiration fluid flow. One of the catheters, designated as an“intermediate” catheter includes an externally mounted lumen structurefor receipt of an inner catheter therethrough. This lumen structure mayinclude a longitudinally extending slit or weakened area along theentire length of the lumen structure to facilitate faster and easierinsertion and removal of the inner catheter through the side wall of thelumen structure. By inserting and removing the inner catheter throughthe slit in the side wall of the lumen structure, the need to removeadapters and attachments from the proximal end prior to slidablyadvancing or removing the intermediate catheter over the inner catheteris eliminated. Thus, this lumen structure which is mounted at the distalend of the intermediate catheter for accommodating the inner catheterenables the intermediate catheter to be guided along the inner catheterin a manner like the heretofore discussed mono-rail catheters are slidalong a guide-wire. However, unlike the prior art devices for mountingan instrument on a guide-wire in a mono-rail like arrangement, thedevice of Zadno-Azizi et al. patent does not require access to theproximal end of the intermediate catheter or guide-wire. Instead thedevice of the Zadno-Azizi et al. patent enables the inner catheter to beinserted laterally into a longitudinally extending access slit in thelumen structure at a intermediate location along the inner catheter. Byinserting and removing the inner catheter through the slit in the sidewall of the lumen structure on the distal end of the intermediatecatheter, the need to remove adapters and attachments from the proximalend of the intermediate catheter prior to slidably advancing or removingthat catheter over the inner catheter is eliminated.

While the instrument of the Zadno-Azizi et al. patent appears generallysuitable for its intended purposes, it appears to leave something to bedesired from various standpoints. For example, since the lumen structurewith the access slit is located externally to the intermediate catheterit will necessarily add its diameter to the diameter of the intermediatecatheter, thereby limiting its usefulness to relatively large crossingdiameter lumens. Also, the manner in which the intermediate catheter isattached or mounted onto the inner catheter or guide-wire may besomewhat difficult to achieve, and the additional structure, e.g., theslit bearing lumen structure, on the distal end could cause the distalend to get snagged on stents placed in the vessel. Further still, sincethe slit through which the inner catheter or guide-wire is inserted islinear and extends longitudinally, the inner catheter or guide-wire maycome out of the lumen during the traversal of difficult anatomicalorientations, e.g,. tortuous vascular paths.

SUMMARY OF THE INVENTION

An attachment tool and method of use for facilitating the attachment ofa catheter or elongated instrument having a connector thereon to aguide-wire or other elongated guide member. The tool comprises surfacesarranged to cause the catheter to contact the guide-wire or otherelongated guide member upon the application of a force, e.g., a twistingforce, a longitudinal force, a lateral force, etc., to the tool or tothe catheter or elongated instrument, whereupon the catheter orelongated instrument is attached to the guide-wire or other elongatedguide member.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of the distal end of one embodiment of acatheter constructed in accordance with this invention and shown afterit has been mounted on a conventional guide-wire by a helical connectorforming a portion of the distal end of the catheter;

FIG. 2 is a longitudinal sectional view of the distal end of theembodiment of the catheter shown in FIG. 1;

FIG. 3 is an isometric view of the distal end of another embodiment of acatheter, e.g., a beveled distal end catheter, constructed in accordancewith this invention and shown after it has been mounted on aconventional guide-wire by a “helical-cut” connector forming a portionof the distal end of the catheter;

FIG. 4 is a longitudinal sectional view of the distal end of theembodiment of the catheter shown in FIG. 3;

FIG. 5 is an isometric view of the distal end of still anotherembodiment of a catheter constructed in accordance with this inventionand shown after it has been mounted on a conventional guide-wire by a“pigtail” connector forming a portion of the distal end of the catheter;

FIG. 6 is a longitudinal sectional view of the distal end of theembodiment of the catheter shown in FIG. 5;

FIG. 7 is a reduced top plan view of the embodiment of the cathetershown in FIG. 1;

FIG. 8 is an enlarged top plan view of the portion of the embodiment ofthe catheter shown within the area bounded by the circular broken linein FIG. 7;

FIG. 9 is an isometric view of the distal end of the embodiment of thecatheter shown in FIG. 1 during an initial step in the mounting of thecatheter on the guide-wire;

FIG. 10 is an isometric view similar to FIG. 9 but showing the distalend of the embodiment of the catheter of FIG. 1 during an intermediatestep in the mounting of the catheter on the guide-wire;

FIG. 11 is an isometric view similar to FIGS. 9 and 10 but showing thedistal end of the embodiment of the catheter of FIG. 1 at a still laterstep in the mounting of the catheter on the guide-wire.

FIG. 12 is an isometric view of the distal end of another embodiment ofa catheter constructed in accordance with this invention;

FIG. 13 is an isometric view similar to FIG. 12 but showing the distalend of the embodiment of the catheter of FIG. 12 during an initial stepin the mounting of the catheter on a guide-wire; and

FIG. 14 is an isometric view similar to FIGS. 12 and 13 but showing thedistal end of the embodiment of the catheter of FIG. 12 after thecatheter has been mounted on the catheter on the guide-wire.

FIG. 15 is an isometric view of the open clamshell attachment toolshowing the internal bore and features used to direct the guide-wireinto the internal bore prior to the closing of the clamshell.

FIG. 16 is an isometric view of the catheter attached to the guide-wireinside the funnel of the closed attachment tool.

FIG. 17 is an isometric view of a guide-wire showing a plurality ofcatheters connected thereon, with each catheter have a distal tipconnector such as those engaged with the attachment tool of the currentinvention.

FIG. 17A is a cross-sectional view of an embodiment of the cathetersystem shown in FIG. 17, at section A—A.

FIG. 18 is an isometric view of a guide-wire showing a plurality ofcatheters connected thereon, with a first catheter having a distal tipconnector such as may be engaged with the attachment tool of the currentinvention and a second catheter loaded from the end of the guide-wire.

FIG. 18A is a cross-sectional view of an embodiment of the cathetersystem shown in FIG. 18, at section A—A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the various figures of the drawing wherein likereference characters refer to like parts, there is shown at 20 in FIG. 1the distal end of a tubular instrument, such as an infusate catheter foruse in a intravascular revascularization system, and having a connector22 constructed in accordance with one embodiment of this invention forquickly and easily securing the catheter 20 onto a conventionalguide-wire 24 without requiring access to either end of the guide-wire.

Before discussing the details of the connector 22, it should be pointedout that the subject invention can be used with any type of tubularinstrument, be it a catheter or otherwise, that is arranged to beextended along a guide-wire or other elongated guide member into thebody of a living being to a desired location and without requiringaccess to either end of the guide-wire or other elongated guide member.In the embodiments shown herein the guide-wire 24 is shown as being atubular member, but can, if desired be a solid wire.

The infusate catheter whose distal end is shown in FIG. 1 is shown fullyin the plan view of FIG. 7 and is merely exemplary of any type ofcatheter or tubular instrument for which the subject invention hasapplication and utility (e.g., an angiographic or other diagnosticcatheter, a drug or therapy delivery catheter, a prosthesis deliverycatheter, a revascularization catheter, a ultrasound or vascular filterwire). As best seen in FIG. 7 the catheter 20 basically comprises anelongated tubular body 20A terminating at a distal end 20B at which theconnector 22 of the subject invention is located. The opposite orproximal end of the catheter 22 is in the form of an enlarged hub orconnector 20C for connection to the associated components of therevascularization system (not shown). A central passageway 20D extendsthrough the catheter and terminates at an open free end 20E (FIGS. 7 and1). In the exemplary embodiment of catheter 20, the passageway 20D isarranged to carry an infusate liquid therethrough for ejection viaopening 20E into the portion of the vessel being revascularized ordiagnosed.

Turning now to FIG. 1 the details of the connector 22 will now beconsidered. As can be seen the connector is in the form of a helicalchannel 28 cut into the wall 30 of the catheter at the distal endportion 20B so that it is in communication with the interior passageway20D of the catheter along the entire length of the channel. The channel28 may be of fixed or variable pitch and includes a widened or flaredmouth 32 where it meets or merges with the open free end 20D of thecatheter. It is through this mouth that the guide-wire, catheter orother elongated guide member is inserted into the channel. The opposingsides of said mouth 32 may be radially offset or displaced (not shown),relative to each other, to facilitate the entry of said guide-wire 24into said channel 28. The proximal end of the channel 28 terminates inan elongated slot or exit window 34 that is also in communication withthe interior passageway 20D. It is through the window 34 that theguide-wire exits the channel. Thus, the channel forms a path into whichthe guide-wire can be inserted to slidingly connect the catheter to theguide-wire. As will be discussed in detail to follow, the path isconstructed so that the entry of the guide-wire into and through it canbe facilitated easily, quickly and reliably with only a slight twistingaction. It should be understood that the connector segment of catheter20 can be a stand-alone device which may be positioned or otherwiseattached to a portion (e.g. the distal tip) of any catheter or elongatedmember. For example, the sleeve-like tubular connector system can beprovided in a number of diameters and lengths and can be slide onto theend of a variety of compatible catheters or elongate members and thensecured in place (e.g. crimped).

In accordance with one preferred aspect of this invention the materialmaking up the connector portion of catheter 20 is preferably resilientso that the guide-wire 24 can be extended into the mouth 32 of thechannel and then into contiguous portion of the channel 28, whereuponthe channel flexes open somewhat to enable the guide-wire to passtherethrough to exit from the window 34. As the guide-wire movesproximally along the channel to the window 34, portions for the channeldistally of the guide wire flexes back to the initial position,whereupon when the guide-wire is within the window, the channel willhave assumed its unflexed or normally closed condition. It should,however, be pointed out at this juncture that the catheter or thematerial forming slot need not be resilient, so long as the slot canaccommodate the guide-wire therein to enable it to slide with respectthereto, as will be described later.

In order to facilitate the exit of the guide-wire 24 from the channel 28at the window 34 and to ensure that the guide-wire extends closelyparallel to the outer surface of the catheter from its exit pointproximally, an elongate recess or depression 36 is formed in the wall 30of the catheter 20 immediately proximally of the window 34. The recess36 extends along an axis parallel to the longitudinal axis of thecatheter and, as best seen in FIG. 2, inclines upward from its lowestpoint where it merges with the proximal end of the window 34 to thepoint where it terminates at the outer circular surface of the catheterproximally of the window.

In the exemplary embodiment shown the outer diameter of the catheter isapproximately 0.05 inch. The spiral channel 20 forms at least onecomplete revolution about the periphery of the catheter so that theentry mouth 32 is axially aligned with the exit window 34. The width ofthe entrance mouth is approximately 0.025 inch. The width of the exitwindow is greater than the width of the channel 28, e.g., 0.02 inchversus 0 to 0.015 inch. The length of the channel 28 measuredlongitudinally from the open end 20E of the catheter to the proximal endof the window 34 (i.e., the lowest point of the recess 36) isapproximately 0.25 inch. It should be understood that in some instancesit may be desirable that the open end 20E of the connector portion ofthe catheter be beveled or tapered to provide a good fit and smoothtransition when the catheter is advanced along to the guide-wire throughtissue or the vasculature of the living being.

In order to enable the user of the catheter to orient it in the desiredrotational attitude for mounting onto the guide-wire, a process to bediscussed in detail later, an indicator marker or indicia, such as anarrow 38, is provided on the catheter aligned with the flared mouth 32so that the user of the catheter can readily determine the location ofthe channel's mouth 32 by viewing the indicator arrow 38.

The mounting of the catheter 20 on the guide-wire 24 will now bediscussed with reference to FIGS. 9-11. It is assumed that theguide-wire is already in place so that its distal end (not shown) islocated at some internal situs within the body of the being, while itsproximal end is located outside the body of the being, with someintermediate portion, designated by the reference number 24A herein,also being located outside the body of the being distally of theproximal end of the guide-wire. It is at this intermediate position thatthe catheter 20 is mounted on the guide-wire using the connector 22. Itshould be pointed out at this juncture that while the portion 24A of theguide-wire is preferably outside the body of the being, such anarrangement is not required. In this regard in some medical applicationsthe guide wire portion 24A where the catheter is to be connected may belocated internally of the being and access provided to it via a naturalbody orifice or opening or through some surgically formed opening.

In any case, as best seen in FIG. 9 the catheter 20 is oriented ortwisted so that the entry mouth 32 at the distal end of the channel isaligned with the portion 24A of the guide-wire 24. The arrow indicia 38facilitates the correct orientation alignment procedure. Once alignedthe distal end of the catheter 20 is moved in a lateral direction (e.g.,from the side of the guide-wire) toward it (or the guide-wire is movedtoward the catheter) so that the guide-wire portion 24A enters into themouth of the channel 116. Then the catheter is twisted or rotated in thedirection shown by arrow 40 to cause the guide-wire portion 24A to enterinto the contiguous portion of the channel 28, whereupon the channelflexes open, as described earlier. Continued twisting of the catheter inthe direction of arrow 40 causes the guide-wire to move further down thechannel as shown in FIG. 11. Continued twisting of the catheter withrespect to the guide-wire in the direction of arrow 40 eventually bringsthe guide-wire portion 24A into the exit window 32, as shown in FIGS. 1and 2, whereupon the guide-wire portion 24 exits the window and isguided upward by the inclined recess 36 until it is generally parallelto the outer surface of the catheter 20 (as best seen in FIG. 1). Oncethis has been accomplished, the catheter can be slid or moved in thedistal direction along the guide-wire to bring the open distal end 20Eof the catheter to the desired position within the being's body, e.g.,at a situs of the atherosclerotic deposit to be removed.

In FIGS. 3 and 4 there is shown an alternative embodiment of a catheter20 constructed in accordance with this invention. The catheter 20 is inall material respects identical to the catheter 20, except for the shapeof its distal end. Thus, in the interest of brevity the details of theconstruction and the operation of the catheter 20 will not be reiteratedand the same reference numbers will be given to the common components.As can be seen in FIGS. 3 and 4 the distal end of the catheter 20includes a beveled end 20E. The entry mouth to the channel 28 is locatedon the most proximal portion of the beveled end 20E for initial receiptof the guide-wire portion 24A therein.

In FIGS. 5 and 6 there is shown another embodiment of a catheter 100constructed in accordance with this invention. The catheter 100 alsoincludes a connector 102 (to be described in detail hereinafter) forfacilitating the mounting of the catheter on a portion 24A of theguide-wire from a lateral or side direction and without requiring accessto either end of the guide-wire. However, unlike the embodiments ofFIGS. 1-4, the connector 102 of the catheter 100 is located externallyto the outer surface of the distal end of the catheter 100 to form thepath or channel for the guide-wire therebetween.

The connector 102 basically comprises a helical wire having pluralconsecutive helices 104 and terminating at one end in a distal endportion 106 and at the opposite or proximal end portion 108. The distalend portion 108 is linear and is centrally disposed within the helices104 (See FIG. 6). The distal end portion is arranged to be fixedlysecured in a central bore 110 in the distal end of the catheter 100. Ascan be seen the distal end of the catheter is closed, e.g., it includesa dome-shaped end wall 112 into which the bore 110 extends. Since theend of the catheter 100 is closed, if it is to be used as an infusatingdevice it includes plural outlet ports or openings 116 extending throughthe sidewall 30 of the distal end portion and in communication with thecentral passageway 118 of the catheter. The helices 104 extend backwardfrom the distal end portion 106 of the connector 102 and about theperiphery of the outer surface of the catheter 100 to form an annularspace or channel 120 therebetween. The thickness of the channel is justslightly greater than the outside diameter of the guide-wire (forreasons to be explained later). The proximal end portion 108 terminatesin a somewhat bulbous free end 122 which is also spaced from the outersurface of the catheter and which forms the entry mouth for the channel120. The connector 102 may be formed of any suitable biocompatiblematerial, e.g., stainless steel, plastic, etc.

The mounting of the catheter 100 on the guide-wire portion 24A isaccomplished by orienting or aligning the catheter 100 so that theguide-wire portion can be inserted into the entry mouth, i.e., the spacebetween the bulbous distal free end 122 of the connector 102 and theouter surface of the catheter 100. Once aligned the distal end of thecatheter 100 is moved in a lateral direction (e.g., from the side of theguide-wire) toward it (or the guide-wire is moved toward the catheter)so that the guide-wire portion 24A enters into the mouth of the channel120. Then the catheter 100 is twisted or rotated in the direction shownby arrow 40 to cause the guide-wire portion 24A to enter into thecontiguous portion of the channel 120, i.e., the helical portion definedby the helix closest to the free end 122. Continued twisting of thecatheter in the direction of arrow 40 causes the guide-wire to movefurther down the channel, guided by the helices 104 until it exits fromthe channel at the distal most helix 104. At this time the guide-wirewill be within the confines of the channel and disposed parallel to andvery closely adjacent to the outer surface of the catheter. Once thishas been accomplished, the catheter 100 can be slid or moved in thedistal direction along the guide-wire 24 to bring the distal end of thecatheter to the desired position within the being's body, e.g., at asitus of the atherosclerotic deposit to be removed.

In accordance with one preferred aspect of this invention the diameterof the wire making up the connector 102 is quite small, e.g., 0.010inch, and the thickness of spacing between the inner surfaces of theconnector's helices 102 and the outer surface of the catheter 100 (i.e.,the thickness of the annular channel 120) is just slightly larger thanthe outside diameter of the catheter. Thus, the catheter 100 with theconnector 102 thereon will still exhibit a small crossing diameter(albeit somewhat greater than a comparable diametrically sized cathetermaking use of the connectors like shown in FIGS. 1-4).

In FIGS. 12-14 there is shown yet another alternative embodiment of acatheter 200 constructed in accordance with this invention. The catheter200 is similar to the catheter 20 in that it is a hollow tubular memberhaving a central passageway 20D terminating at an open distal end 20E,yet is also similar to the catheter 100 in that catheter 200 includes anexternally located connector 202. The connector 202 is like the otherconnectors described heretofore arranged to enable a guide wire 24 orother elongated guide member to be readily connected to the catheter byinserting it into a path (to be described hereinafter) by a twistingaction, whereupon the catheter or other instrument can be slid along theguide-wire or other elongated guide member, yet is resistant toaccidental disconnection.

As can be seen the connector 202 basically comprises a sleeve 204 formedof any biocompatible material, like those described heretofore, andhaving a pair of fingers 206 and 206 projecting outward therefrom. Thesleeve 204 includes a circular central passageway whose inside diameteris approximately the same as the outside diameter of the distal endportion of the catheter 200 to accommodate that portion of the catheterextending therethrough. The sleeve is secured in place by any suitablemeans, e.g., an adhesive, by friction fit, etc. Moreover, the sleeve maybe integrally formed on the distal end portion of the catheter. In fact,as will be appreciated from the discussion to follow, the use of asleeve may be eliminated if the connector is formed integrally with thecatheter. In such an arrangement, all that is required is that distalend of the catheter include the fingers 206 and 208 to form theguide-wire receiving path.

Each of the fingers 206 and 208 projects outward from the longitudinalaxis of the connector and the longitudinal axis of the distal end of thecatheter 200. Each of the fingers includes an overhanging, e.g.,arcuate, free end 210. The free end of the respective fingers aredirected in opposed directions to each other, i.e., they are directed sothat they face each other but are offset from each other in thelongitudinal direction. In particular, the free end 210 of the finger206 is directed from one side of the catheter 200 towards the free end210 of the finger 208 on the other side of the catheter. The fingers 206and 208 may extend tangentially, radially or at some other orientationaway from the central longitudinal axis of the catheter 200 so that thefree end 210 of the finger 206 and the free end 210 of the finger 208each form a respective portion of a channel or path 212 between them andthe portion of the sleeve from which they project (or from the portionof the catheter from which they project if no sleeve is utilized, e.g.,the fingers are formed integrally with the catheter 200.

In the preferred embodiment shown herein the path 212 is of a generallycircular cross-section and extends linearly along the longitudinal axisof the catheter immediately adjacent the outer surface of the sleeve204. It is in this channel or path 214 that the guide-wire portion 24Aof the guide-wire 24 is arranged to be inserted to slidingly mount thecatheter on the guide-wire. In accordance with a preferred embodiment ofthis invention the free ends 210 of the fingers 206 and 208 extendaround the periphery of the guide-wire so that the fingers andcontiguous portion of the sleeve each engage or encircle more than 180degrees of the periphery of the guide-wire when the guide-wire is withinthe path or channel to prevent the guide-wire from accidentally comingout of the path or channel. The entry point or entrance to the path orchannel 212 is provided by the space or gap 214 between the fingers 206and 208.

In order to minimize the crossing-diameter of the catheter 200, thefingers 206 and 208 of the connector are preferably dimensioned to keeptheir height or projection from the central longitudinal axis of thecatheter 200 as short as possible, while still enabling the guide-wireportion 24A to be held securely in the path 212 for sliding movementresistant to accidental disconnection. Thus, in the preferred embodimentshown in the cross-sectional area of the channel 212 is just slightlylarger than the outside diameter of the guide-wire 24A and the fingersare very thin.

The connection of the catheter 200 to the guide-wire portion 24A willnow be described with reference to FIGS. 13 and 14. As before, it isassumed that the guide-wire 24 is already in place so that its distalend (not shown) is located at some internal situs within the body of thebeing, while its proximal end is located outside the body of the being,with the intermediate portion 24A of the guide wire also being locatedoutside the body of the being distally of the proximal end of theguide-wire. As pointed out earlier while the portion 24A of theguide-wire is preferably outside the body of the being, such anarrangement is not required. In this regard in some medical applicationsthe guide wire portion 24A where the catheter is to be connected may belocated internally of the being and access provided to it via a naturalbody orifice or opening or through some surgically formed opening.

In any case, as best seen in FIG. 13 the catheter 202 is oriented sothat the entry mouth or gap 214 of the path 212 at the distal end of thechannel is aligned with the portion 24A of the guide-wire 24, e.g., thelongitudinal axis of the guide-wire portion 24A is perpendicular to thelongitudinal axis of the catheter 200 and is between the fingers formingthe gap. Once so aligned the distal end of the catheter 20 is twistedabout an axis perpendicular to the longitudinal axis of the catheter tobring the more distally located portion of the guide-wire portion 24Ainto the path 212 under the finger 206, while at the same time bringingthe more proximally located portion of the guide-wire portion 24A intothe path 212 under the finger 208 as shown in FIG. 14. This actioncompletes the sliding securement of the catheter on the guide-wire 24.Therefore, once the sliding securement has been accomplished, thecatheter 200 can be slid or moved in the distal direction along theguide-wire 24 to bring the open distal end 20E of the catheter to thedesired position within the being's body, e.g., at a situs of theatherosclerotic deposit to be removed.

It should be pointed out at this juncture that while the foregoingdiscussion has described the twisting of the catheter or other tubularinstrument with respect to the guide-wire or other elongated guidemember to releasably secure the two together, that methodology is notthe only method for achieving their releasably securement. Thus, as willbe appreciated by those skilled in the art, the guide-wire or otherelongated guide member can be twisted with respect to the catheter orother tubular instrument to cause the guide-wire or other tubularinstrument to be introduced into the path for holding the two together.

It should also be pointed out that while the foregoing discussion hasdescribed catheters or other tubular instruments with the various typesof connectors forming a portion thereof, it should be clear thatconnectors, per se, may be constructed in accordance with this inventionfor mounting, e.g., retrofitting, to existing catheters or other tubularinstruments. Thus, the subject invention not only contemplates cathetersor other elongated tubular instruments including connectors forconnecting the catheters or other tubular instruments to guide-wires orother elongated guide member, but also contemplates connectors, per se,for use with conventional catheters to achieve those ends.

In a preferred embodiment an attachment tool 300 comprises a hingedclamshell construction, that when closed provides for an interiorlongitudinal bore 301 for the guide-wire (or other elongated guidemember) that expands into a conical funnel portion 302 at the leadingend (proximal end) 310 of the tool. The tool further comprises twohalves, a first half 303 on which is located on a pair of raised v-shapeprotrusions 304 through which the guide-wire 24 is placed into the bore301. The raised protrusions 304 are arranged co-linear with a bore 301,and on either side of same, to allow for easy placement of saidguide-wire, and also engage the second half of the tool 305 in a matingdepressed portion 306. The engagement of the protrusion of the firsthalf and the depression of the second half, during closing of the tool300 by rotating 330 one half of tool, serve to align the closed tool,thereby creating a smooth funnel opening 302, or catheter entry port.Living hinges 307 allow for one-handed closure of the tool around theguide-wire 24 (not shown), a small indentation 308 provides for a tab toopen the closed tool to remove it from the attached catheter-guide-wireapparatus. The bore 301 extends the full length of the first half 303,and can be utilized for guide-wire alignment at the distal end 309opposite the funnel opening 302.

The tool 300 is intended to be closed over the guide-wire 24, as isshown in FIG. 16, whereby the guide-wire shall then reside within thebore 301 inside the closed tool. The catheter 20 containing the distaltip connector 28 (e.g., one of the various embodiments previouslydescribed) is then advanced into the open funnel portion of the tool302, and the catheter is simultaneously advanced 311 and twisted 40 toeffect attachment of the connector 310 to the guide-wire (as previouslydescribed). The conical funnel 302 serves to press the catheter againstthe guide-wire, facilitating the entry of the guide-wire into the mouth32 provided at the entry of the helical channel 28.

In yet another embodiment, said attachment tool 300 causes alignment ofsaid guide-wire 24 and said catheter 20, as shown in FIG. 16; however,the tool of this embodiment further utilizes a detent to facilitateengagement of said guide-wire 24 with said channel 28, wherein saiddetent comprises a mouth 32 (as shown in FIG. 1) or an offset (notshown), as previously described herein.

Once the catheter is fully attached, the tool is then opened with tab308 to release the guide-wire, and the catheter can be advanced orretracted freely and securely along the wire. This exemplary toolembodiment is designed to be functional and easy-to-use with one hand,but other embodiments causing contact and engagement of the catheter andwire are anticipated and within the concept of the present invention.

The attachment tool 300 may be sized to allow its insertion into anatural body orifice, or other surgical created entry site, wherein saidtool may attach a plurality of catheters while said tool is locatedentirely inside of the body. It is within the concept of this inventionto operate the attachment tool with hands, fingers, or otherinstruments, thereby enabling the attachment of catheters to aguide-wire at various remote areas within the body.

The longitudinal bore 301 arranged therebetween the proximal and distalends of said tool 300 allows communication through the tool. Thiscommunication allows catheters or other instruments comprisingfunctional members (not shown) located distal to the distal tipconnector, and attached thereto, to be arranged in the bore 301 suchthat said member extends through the distal end 309 of said tool 300. Asa non-limiting example, said functional member may comprise a steeringtip (for steering the functional member, and catheter, independently ofguide wire 24), an angioplasty balloon (with or without a steering tip,which may be used to occlude an arterial branch), or a catheter for thedelivery of a therapy or diagnostic equipment (e.g., a drug,biologically active agent, radioactive source, ultrasonic source, orother prosthesis).

Since the distal tip connector, as previously described, does not needaccess to the ends of the guide-wire, a plurality of catheters may beattached to the guide-wire while the guide-wire is in-place (i.e.,extending into the body, to the site of the procedures) withoutrequiring access to the end of the guide-wire. A preferred embodiment ofthe attachment tool, of the present invention, facilitates thisattachment.

As an example, FIG. 17 shows a plurality of catheters each comprising achannel-type of distal tip connector 28 (such as that shown in FIG. 1);wherein a guide-wire 24 has a first catheter 400 attached (said firstcatheter may contain a radio-opaque marker 401, to ease the loaction ofsaid catheters during the procedure), and a second catheter 410 attachedproximally to said first catheter. The attachment tool 300 (as shown inFIGS. 15-16) facilitates this multiple catheter system, and the numberof catheters is limited only by the crossing diameter of the artery.

The benefits of this attachment tool and this type of multiple cathetersystem can readily be seen in FIG. 17A, wherein the cross-section showsthe non-concentric arrangement of the catheters and guide-wire. Aspreviously described, the flow or access through the catheters is notimpeded, that is, neither the first catheter 400, nor the secondcatheter 410 need to house other catheters or guide-wires. Theguide-wire 24 enabling the placement of said catheters is external toeach catheter. The first catheter's flow 404, as well as the secondcatheter's flow 414, remains unrestricted.

This free flow through a plurality of catheters allows or improves theability to perfuse diagnostic or therapeutic fluids and drugs.Additionally, higher pressures and/or flow rates facilitates the removalof fluids and/or debris. As an example, FIG. 18 shows a plurality ofcatheters on a single guide-wire. A guide-wire 24 has a first catheter400 attached, and a second catheter 420 attached proximally to saidfirst catheter. However, in this figure the first catheter 400 isattached via a channel-type of distal tip connector 28, while the secondcatheter 420 is threaded over the guide-wire 24 in a more traditionalconcentric loading configuration.

The concentric loading method restricts the flow; as can be seen in FIG.18A, the second catheter 420 loaded over the guide-wire 24 has reducedflow 424 characteristics, when compared to the first catheter's flow404.

FIG. 18 also shows an example of a procedure capable with a plurality ofcatheters. A distal balloon 406 provides protection from debris 403travelling distally from the procedure, which may cause a stroke, heartattack, or other pulmonary event. Said debris 403 being liberated from aplaque deposit 402 by fluid flow 434 emanating from the distal opening404 of the first catheter 400 (said flow 434 may be complemented byadditional flow 34 from the proximal end or window 34 located at theproximal end of said distal tip connector 28); said debris 403 beingremoved with the artery or vessel along with the debris stream 422through the distal opening 424 in the second catheter 420. This figureis merely exemplary of the benefits of a multiple catheter system, whileit is recognized that it may not be as efficient as a system employingmultiple non-concentric catheters, as is shown in FIG. 17; all of whichis facilitated by an embodiment of the attachment tool 300 of thepresent invention.

Without further elaboration the foregoing will so fully illustrate ourinvention that others may, by applying current or future knowledge,adopt the same for use under various conditions of service.

1. A method of facilitating the attachment of a catheter or elongatedinstrument to a guide-wire or other elongated guide member, withouthaving access to the ends of said wire or member, comprising: a)supplying an attachment tool comprising a first and second half, a hingearranged to connect said halves, said hinge allowing relative pivotingof said first half with respect to said second half such that saidhalves come together closing said tool, said first half comprising apair of raised V-shape protrusions, said second half comprising adepression wherein said protrusions are forced into said depression uponthe closing of said tool, thereby causing alignment of said first andsecond half, said first half further comprising a longitudinal borearranged to accept a guide-wire or other elongated guide member, saidtool further comprising a proximal end and a distal end, said first andsecond halves each further comprising a half-funnel shaped entry portsection located at the proximal end of said tool, whereby both of saidentry port sections create a smooth funnel shaped entry port for easycatheter or instrument insertion, following the closing of said toolwith said guide-wire or member located between said protrusions, saidentry port arranged to guide said catheter or instrument to saidguide-wire or elongated guide member, to facilitate attachment of saiddistal tip connector thereon; b) supplying a catheter or instrument tobe attached to a guide-wire or elongated guide member; c) closing saidattachment tool on said guide-wire or elongated guide member; d)inserting said catheter or instrument into said entry port and applyinga force thereto until resistance is felt; and e) opening said tool andremoving wire or member from said longitudinal bore.
 2. A method offacilitating the attachment of a catheter or elongated instrument to aguide-wire or other elongated guide member, without having access to theends of said guide-wire or elongated guide member, comprising: a)supplying an attachment tool comprising a longitudinal bore, an entryport in communication with said bore, and surfaces arranged to causesaid catheter to contact said guide-wire or elongated guide member uponthe application of force thereto, said contact thereby effectingattachment; b) supplying a catheter or elongated instrument to beattached to a guide-wire or elongated guide member; c) closing saidattachment tool on said guide-wire or elongated guide member; d)inserting said catheter or elongated instrument into said entry portwhile applying force until resistance is felt; and e) opening said tooland removing said guide-wire or elongated guide member from saidlongitudinal bore.
 3. The method of claim 2, wherein said guide-wire orelongated guide member is located outside the body.
 4. The method ofclaim 2, wherein said guide-wire or elongated guide member is locatedinside the body.
 5. The method of claim 4, wherein said attachment toolis arranged for location inside the body, said method furthercomprising: f) removing said tool from inside said body.
 6. The methodof claim 2, wherein said force comprises twisting.
 7. The method ofclaim 2, wherein said force comprises longitudinal force.
 8. The methodof claim 2, wherein said force comprises lateral force.
 9. A method offacilitating the attachment of a plurality of catheters or elongatedinstruments to a guide-wire or other elongated guide member, withoutaccess to the ends of said guide-wire or other elongated guide member,comprising the method of claim 1, wherein said method further comprises:f) re-closing said attachment tool on said guide-wire or elongated guidemember; g) inserting a second catheter or elongated instrument into saidport while applying force until resistance is felt; and h) opening saidtool and removing said guide-wire or elongated guide member from saidlongitudinal bore.